Creating and Maintaining a GMP Quality System

The webinar will discuss basic/key requirements for creating and maintaining a GMP compliant quality system in the FDA regulated industries.

In this webinar,
You will gain the knowledge base for operating in a GMP compliant environment
You will have a better understanding of the basic requirements that FDA seeks in the FDA regulated industries
Speaker will layout the basic knowledge base for the top requirements for a GMP complaint quality management system (QMS)

Areas Covered in the Session :
Good Manufacturing Practices – Overview
Quality Management System – Overview
Key requirements for creating an FDA compliant Quality Management System
Prerequisites for meeting GMP compliance
Interactive Q&A Session

Who Will Benefit:
Quality Assurance Professionals
Quality Control Professionals
Regulatory Professionals
Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams
Pharma/Medical Devices/OTC Cosmetic Packaging Teams
Pharma/Medical Devices/OTC Cosmetic Subcontractors
Contract Testing Laboratories
Owners/Presidents of GMP regulated companies

Jan L. Warner

Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: pharmaceutical, medical device, OTC and personal care, homeopathic drugs, dietary supplements and cosmetics.

He has held numerous upper management responsibilities in quality assurance, compliance and quality control. He is the owner of IQA Consulting Services; a niche provider of quality and compliance services to the FDA and similarly regulated industries. Jan has extensive experience working for Fortune 500 as well as start-up companies.

His expertise encompasses the following:

  • Product types: Pharmaceuticals (Rx and OTC), medical devices, IVDs, veterinary products, injectables, cosmetics, chemical ingredients and actives, and biologics
  • FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs
  • Creation, implementation and management of Quality Systems for the following standards: GXP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI
  • Manufacturing, Quality and Complaint investigations
  • Training, technical writing and SOP development
  • CAPA and change control management
  • FDA Field Alerts, 483s, recalls and consent decree remediation
  • Supplier, API, contract manufacturing and packaging, internal and third party auditing

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance